Kornimate/medical-research-clean huggingface dataset:
triage assessment and news-score as risk predictor in older frailty adults in the ed

Conditions: Frailty; Aged; Triage

Summary: emergency department triage systems have not been shown to sufficiently recognize frail elderly patients in need of urgent assessment and care. in this prospective, observational study the performance of the 3-level triage system and the national early warning score (news) 2 are assessed (separately and combined) for predicting adverse outcomes in older frailty patients visiting in the ed. observational data for this study is gathered as part of gaops - main study (clinicaltrials.gov identifier: nct03751319).


Eligibility criteria:
inclusion criteria: * "clinical frailty scale" minimum 4 estimated at the arrival to the ed by nurse exclusion criteria: • non-resident of the counties (city of espoo, kirkkonummi, kauniainen) of the hospital district.

Keywords: emergency triage
a trial to evaluate laparoscopic versus open surgery for colorectal cancer

Conditions: Colorectal Cancer

Summary: the purpose of this study is to evaluate oncological outcome of patients for t3 and t4 colorectal cancer undergoing laparoscopic versus open surgery.

the benefits of laparoscopic surgery (lap) in comparison to open surgery (open) have been suggested with respect to decreased morbidity, decreased pain, faster recovery, and shorter hospital stay.1-4 however, the long-term survival of lap for colorectal cancer is still unclear, especially for advanced colorectal cancer requiring extended lymphadenectomy. thus, the investigators designed a study which investigates whether lap is suitable for advanced colorectal cancer with respect to survival and post-operative morbidity.

Eligibility criteria:
inclusion criteria: 1. histologically proven colorectal carcinoma 2. tumor located in the cecum, ascending colon, sigmoid colon, or rectosigmoid colon 3. t3 or deeper lesion without involvement of other organs 4. without multiple lesion other than carcinoma in situ 5. cancer classified as n0-2 and m0, according to the tnm classification system 6. tumor size \< 8 cm 7. no bowel obstruction 8. age 20 \ 75 years 9. sufficient organ function 10. no history of gastrointestinal surgery 11. no history of chemotherapy or radiotherapy 12. provided written informed consent exclusion criteria: 1. synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ 2. severe pulmonary emphysema, interstitial pneumonitis, or ischemic heart disease 3. pregnant or lactating women 4. severe mental disease 5. continuous systemic steroid therapy

Keywords: colorectal cancer laparoscopic surgery randomized controlled trial oncological outcome
the t2d profile - studies of the omics profile in type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the t2d profile study examines the longitudinal molecular profiles of newly diagnosed type 2 diabetes (t2d), before and during guideline-based diabetes treatment.

the study included a total of 3 visits: at baseline and after 1 and 3 months of diabetes treatment according to standard of care. visits included clinical examinations, questionnaires and clinical chemistry. in addition, samples were collected at each visits for comprehensive molecular profiling including proteomics, genomics, transcriptomics, metabolomics, lipidomics, antibody profiling, mass cytometry and gene profiling of fecal microbiota.

Eligibility criteria:
inclusion criteria: * signed informed consent to participate in the study. * age 50-65 years. * t2d diagnosis (fasting p-glucose ≥7.0 mmol/l or an oral glucose tolerance test 2 hour p-glucose ≥11.1 mmol/l \[or ≥12.2 mmol/l if measured capillary\] at two separate occasions). exclusion criteria: * diabetes medication before study start. * severe hyperglycemia requiring hospitalization or immediate insulin treatment, as judged by the investigator. * presence of any clinically significant disease which, in the opinion of the investigator, may interfere with the subject´s ability to participate in the study. * any major surgical procedure or trauma within 4 weeks of the first study visit.
hypertonic solution in off pump coronary artery bypass graft surgery

Conditions: Coronary Artery Disease

Summary: this is a comparison between hypertonic versus isotonic solution in a double blind randomized trial for off pump coronary artery bypass graft (cabg) surgery targeting the left marginal branch. hypertonic solution should provide better tolerance for heart mobilization with less volume expansion and less drugs.


Eligibility criteria:
inclusion criteria: * off pump cabg targeting the left marginal branch exclusion criteria: * on pump surgery

Keywords: coronary artery bypass off-pump saline solution hypertonic
cd-probe: cervical dystonia patient registry for the observation of onabotulinumtoxina efficacy

Conditions: Cervical Dystonia

Summary: this study is an observational trial which will measure the efficacy of onabotulinumtoxina in treating cervical dystonia.


Eligibility criteria:
inclusion criteria: * diagnosed with cervical dystonia * candidate for botulinum toxin type a therapy * new to physician's practice, and/or new to botulinum toxin type a therapy, or has not been injected with botulinum toxin type a for at least 16 weeks as a participant in another clinical trial investigating botulinum toxin type a for cervical dystonia * able to follow study instructions and complete study activities exclusion criteria: * patients undergoing elective surgery during the trial period * females who are pregnant, nursing, or planning a pregnancy * history of poor cooperation or compliance with medical treatment or unreliability * any condition or situation in which, in the investigator's opinion, places the patient at significant risk, could confound the study data, or may interfere with the patient's participation in the study, including but not limited to unstable medical conditions
growth hormone replacement therapy in veterans with mild traumatic brain injury (mtbi) and adult growth hormone deficiency (aghd)

Conditions: Adult Growth Hormone Deficiency; Mild Traumatic Brain Injury

Summary: the purpose of this study is to determine whether growth hormone replacement therapy (ghrt) is effective versus placebo in the improvement of quality of life in patients with adult growth hormone deficiency (aghd) and mild traumatic brain injury (mtbi).


Eligibility criteria:
inclusion criteria: * oef/oif/ond veteran * score of 18 or more on combat experiences sub-scale of deployment risk and resilience inventory-2 (drri-2) * age 21 - 55 years old * one or more mtbi sustained during military service at least 12 months prior to the screening date, as noted via the craft survey * gh deficiency diagnosed by: macimorelin stimulation test (cut point 5.1 mcg/l) and igf-i lab values have to be less than or equal to +1 sds at baseline * score of 11 or more on qol-aghda * 4-week stability on any psychotropic medications * 3-month stability on all other hormone treatments * able and willing to provide informed consent to participate in this study, and complete study protocol. exclusion criteria: * history of moderate or severe tbi * history of neurologic disorder other than tbi with substantial impact on quality of life * history of bipolar disorder, schizophrenia, or other concurrent psychotic disorder * active suicidal ideation (no plan required) as determined by a score of 2 points or more on the columbia suicide severity rating scale (c-ssrs) suicidal ideation rating, or overt suicidal behavior in the past 6 months * contraindication to rhgh therapy * contraindication to macimorelin use, including qtc interval \>470ms * acute medical illness, active infection, cancer or decompensated chronic medical illness * evidence of substance use disorder, -other than mild alcohol or cannabis use disorder-, or urine toxicology evidence of the use of an illicit drug (excluding cannabis), in the past 6 months. nicotine use is allowed. * score less than or equal to 41 on trial 2 or retention trial of the test of memory malingering (tomm). * bmi \> 35 or body weight \> 350 lbs * pituitary anatomy documented by an mri using a sella protocol within the last 2 years indicating abnormalities consistent with an etiology other than mild-tbi (i.e.; pituitary mass) * women who are pregnant or of child-bearing potential not on contraception * current use of the following: growth hormone, estrogen or estrogen-like dietary supplements, progestin, igf-i, or chronic glucocorticoid use in supraphysiologic doses * currently enrolled in any other interventional study unless prior approval is provided by the study chairs and the study sponsor (cooperative studies program)
nerve stimulation using a tens to provide pain relief during surgery for overactive bladder

Conditions: Urinary Incontinence; Overactive Bladder; Pain, Acute

Summary: this will be a double blind randomized control trial in men and women with urinary urge incontinence that are undergoing outpatient operative cystoscopy for onabotulinumtoxin a chemo denervation as third line therapy for overactive bladder (oab) or urinary urge incontinence (uui). subjects will be identified by the university of rochester urologists and urogynecologists participating in the study who currently oversee urinary urge incontinence care. subjects will be randomized into two groups. one group will be undergoing the cystoscopy with transcutaneous electrical nerve stimulation (tens) for analgesia and the second group will have cystoscopy with placebo tens.


Eligibility criteria:
inclusion criteria: * men and women, age ≥18 years * diagnosis of oab/uui, * scheduled to undergo intravesical botox injections in the office * able to read/write english exclusion criteria: * currently undergoing sacral neuromodulation * cutaneous damage such as ulcers or broken skin on target treatment area * currently implanted cardiac pacemaker or defibrillator * pre-procedural use of opioids for pain management, less than 8 hours from last dose * participants with altered sensation below the umbilicus
safety evaluation of advantage anti-caries varnish

Conditions: Dental Caries

Summary: the purpose of the study is to confirm the safety of advantage anti-caries varnish.

this is an open-label phase 1 study. the active ingredients are povidone iodine and sodium fluoride \[therametrics technologies, inc, noblesville, in, usa\]. the oral soft tissues and teeth of the children will be examined and the test varnish to the teeth. the child will be re-examined at 24-48 hours for the presence of adverse oral soft tissue changes. at the follow-up, a qualified dental provider will ask questions focused on adverse events.

Eligibility criteria:
inclusion criteria: * healthy exclusion criteria: * weight less than 15 kg or hypersensitivity to iodine
the role of inflammation in ocular tumours

Conditions: Ocular Melanoma

Summary: this prospective, non-therapeutic study will determine whether a novel imaging technique can identify presumptive tumour associated macrophages (tams) in patients with ocular tumours. the investigators will evaluate 5 groups: 1. choroidal nevus 2. choroidal indeterminate melanocytic lesion 3. choroidal melanoma 4. suspected metastatic tumour (ie, primary tumour elsewhere) 5. locally treated ocular tumours


Eligibility criteria:
inclusion criteria: any tentative clinical diagnosis of: 1. choroidal nevus (low-risk features): 2. choroidal indeterminate melanocytic lesion (high-risk features) 3. choroidal melanoma 4. suspected metastatic tumour (ie, primary tumour elsewhere) 5. locally treated ocular tumours note that a patient can enroll in this study twice, once before treatment and once after, provided that at least one month has passed since initiation of treatment. this patient will count twice (ie, once in each of two study arms) male and female age 18 years and older ability to provide informed consent exclusion criteria: * allergy to angiography dye * cases that do not meet the above criteria for tumor size will be ineligible to participate in the study. * patients not able to provide consent for the study. * patients with a poor view of the fundus due to cataract or vitreous hemorrhage. * patients \< 18 years of age. any concurrent unrelated eye diagnosis
a universal primary care based pilot intervention to reduce youth overdose risk

Conditions: Overdose

Summary: adolescent (ages 10-19) overdose deaths are the third leading cause of pediatric death and continue to rise in the united states. healthcare providers have regular and trusted relationships with youth and have experience in providing public health injury prevention counseling. youth have different motivations for using drugs, and many who experience fatal overdose do not have a history of opioid use. primary care pediatric providers regularly provide developmentally appropriate injury prevention counseling for leading causes of pediatric fatal and nonfatal injury such as drowning prevention and firearms safety. however, there are no recommended, evidence-based overdose prevention interventions for youth, including in health care settings, even though research supports pediatricians and youth-serving clinicians providing harm reduction strategies such as naloxone distribution and overdose education. among adults, overdose prevention education reduces overdose, is cost-effective, and can be learned by laypersons. content commonly includes awareness of fentanyl in the drug supply, risk reduction (e.g., not using alone, risks of polysubstance use), and how to recognize and respond to an overdose, including the use of naloxone. this study is a pilot two-arm cluster randomized controlled trial (rct) of a brief overdose prevention education intervention that will be developed in collaboration with the community advisory board (cab). the primary outcome of this study is to assess the feasibility and acceptability of the brief youth overdose prevention intervention as measured by provider feasibility and acceptability as well as youth acceptability.


Eligibility criteria:
inclusion criteria for providers: * physicians and advance practice providers within pediatric primary care and family medicine at boston medical center (bmc) * ≥ 2 clinic sessions per/week exclusion criteria for providers: * none inclusion criteria for youth: * ages 13-26 * scheduled for a comprehensive physical exam with a provider who is participating in the trial * english speaking exclusion criteria for youth: * caregivers of youth ages 13-17 unable to provide informed consent or are not english speaking * cognitive limitation or intellectual disability that in the opinion of their provider would not * any medical/psychiatric condition that causes acute distress and requires emergency evaluation * under legal custody of the department of children and families (dcf)

Keywords: brief overdose prevention naloxone youth patients health care providers primary care
effect of hypotensive anesthesia on cerebral perfusion and blood antioxidant levels and hif 1a

Conditions: Hypoxemia During Surgery; Hypoxia, Brain

Summary: the aim of this study to evaluate the patients who underwent controlled hypotensive anesthesia under standardized depth of anesthesia; preoperative and postoperative blood hif 1a, tas, tos measurement and cerebral perfusion evaluation with nirs and to investigate tissue hypoxia secondary to hypotensive anesthesia and the changes of the mediators at the tissue level and which blood pressure parameters are related.

controlled hypotension is the voluntary reversible reduction of arterial blood pressure. hypotensive anesthesia is a method of anesthesia in which blood pressure is reduced in a controlled manner, especially in certain surgeries. i̇t reduces intraoperative bleeding and need for blood transfusion and provides a clean surgical vision in narrow-field surgeries or with high bleeding potential. hypotensive anesthesia can be performed according to mean blood pressure (mbp) or systolic blood pressure (sbp). a non-invasive cerebral oximeter is used to see the changes in the brain due to high oxygen-dependent metabolism during induction and maintenance of anesthesia. hypoxia inducible factor (hif) is a transcription factor involved in cell adaptation mechanism activated in response to hypoxia. the biological activity of hif 1 is determined by the expression and activity of the hif 1a subunit. total antioxidant status (tas) shows the total effect of all antioxidants in the human body and total oxidant status (tos) shows the total effect of oxidants. near infrared spectroscopy (nirs) allows continuous and non-invasive monitoring of cerebral oxygenation. hif 1a, tas and tos are laboratory markers that predict tissue oxygenation and perfusion. hypotensive anesthesia can be performed according to both mbp and sbp. however, in our study that follow-up mbp is more advantageous/protective, although it is not supported by very strong data. the investigators recommend hypotensive anesthesia compared to mbp; but further studies are needed.

Eligibility criteria:
inclusion criteria: * 18-75 years old * asa physical status classification system 1-2 * undergoing to elective rhinoplasty or maxillofacial surgery exclusion criteria: * 1. those with svo history 2. patients with carotid stenosis and cardiac failure 3. chronic smoking 4. patients with allergies to drugs to be used 5. patients without intraoperative hypotension 6. presence of morbid obesity (bmi\> 40 kg / m2) 7. patients who refused to participate in the study termination criteria 1. development of severe hypotension and bradycardia during measurements 2. development of severe drug allergy during follow-up 3. in the event of any complications related to the surgical procedure

Keywords: hypotensive anesthesia hif 1a brain hypoxia tissue hypoxia
biological rhythms impact of 12 hours shift work

Conditions: Shift-Work Sleep Disorder

Summary: nonstandard time-schedules work are widespread in the world of work. shift and night work have been shown to be responsible for a desynchronization of biological rhythms, associated with melatonin secretion impairment and sleep disturbances. however, while health consequences of night and shift work are widely recognized and represent a major public health concern (high authority of health 2012 recommendations and national agency for public health food, environment and work 2016 report), the mechanisms by which the circadian system is affected by shift work remain poorly understood. indeed most of the studies in the fields are cross-sectional, based on few blood or urinary samples in a single work position, in workers whose shift work patterns are often misidentified and heterogeneous. moreover, few studies have assessed melatonin secretion alterations in relation to objective sleep measurement (actigraphy). the aim of this study is to assess the dynamics of melatonin secretion adaptation in 12-hour shift work and to correlate these data to sleep-wake cycle recording.


Eligibility criteria:
inclusion criteria: * nurses or nursing assistants working in the sleep and respiratory diseases department of the croix-rousse hospital with positions in 12 hours for more than 6 months * informed consent given by the subject exclusion criteria: * pregnancy or lactation \<6 months * taking treatment modifying the secretion of melatonin (melatoninergic drugs (including antidepressants), beta-blockers) * refusal of participate * minor or major protected subject * not affiliated to a social security scheme * participant in another interventional study interfering with sleep / wake rhythm or work schedules (judgment of the investigator)

Keywords: shift work melatonin sleep
repeating list for refractory non-bacterial prostatitis/pelvic pain syndrome

Conditions: Chronic Prostatitis With Chronic Pelvic Pain Syndrome

Summary: the aim of the study is to investigate the efficacy and safety of list retreatment for cp/cpps patients.a total of 50 patients with cp/cpps diagnosis who were previously treated with 6 sessions of list will participate in this study.the primary study parameter is the cp/cpps-related pain complaints and it will be assessed by the nih-cpsi


Eligibility criteria:
inclusion criteria: 1. participant must be between 18-60 years of age. 2. participant has signed and dated the appropriate informed consent document. 3. participant has had a clinical diagnosis of cp/cpps defined as symptoms of discomfort or pain in the perineal or pelvic region for at least a three (3) month period within the last six (6) months. 4. participant has received 6 sessions (1/week or 2/week, energy level 7, dornier aries 2) of list the last 12 months for the treatment of cp/cpps reporting amelioration but without complete remission of cp/cpps symptoms ( at over 1 upoint positive domain). exclusion criteria: 1. participant has evidence of facultative gram negative or enterococcus with a value of ≥ 1000 cfu/ml in mid-stream urine (vb2). 2. participant has a history of prostate, bladder or urethral cancer. 3. participant has undergone pelvic radiation or systemic chemotherapy. 4. participant has undergone intravesical chemotherapy. 5. participant has unilateral orchialgia without pelvic symptoms, active urethral stricture or bladder stones, or any other urological condition associated with luts, any neurological disease or disorder affecting the bladder. 6. participant has undergone prostate surgery or treatment. 7. participant with penile or urinary sphincter implants. 8. participant has been diagnosed with cancer during the last 5 years, or had any surgery in the pelvis. 9. participant has a neurological impairment or psychiatric disorder preventing his understanding of consent and his ability to comply with the protocol.
open label extension study of 1 mg/kg pegunigalsidase alfa every 2 weeks in patients with fabry disease

Conditions: Fabry Disease

Summary: the objective of cli-06657aa1-04 (formerly pb-102-f60) is to evaluate the long-term safety, tolerability, and efficacy parameters of 1 mg/kg pegunigalsidase alfa administered intravenously every other week in adult fabry patients who have successfully completed studies pb-102-f03, pb-102-f20 or pb-102-f30.

this is an open-label study. patients will be enrolled to receive 1 mg/kg pegunigalsidase alfa as intravenous infusions every 2 weeks (±3 days). the duration of treatment is until pegunigalsidase alfa is commercially available to the patient, or at the discretion of the sponsor. for the analysis, available efficacy and safety parameters will be summarized using descriptive statistics.

Eligibility criteria:
inclusion criteria: 1. completion of study pb-102-f20, pb-102-f03, or pb-102-f30 2. the patient signs informed consent 3. female patients and male patients whose co-partners are of child-bearing potential agree to use a medically acceptable method of contraception. these include combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal) supplemented with a barrier method (preferably male condom), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, or implantable) supplemented with a barrier method (preferably male condom), intrauterine device (iud), intrauterine hormone-releasing system (ius), bilateral tubal occlusion, vasectomised partner, or sexual abstinence. contraception should be used for 2 weeks after treatment termination. exclusion criteria: presence of any medical, emotional, behavioral or psychological condition that, in the judgment of the investigator, would interfere with patient compliance with the requirements of the study.

Keywords: glomerular filtration rate proteinuria prx-102 pegunigalsidase alfa fabry disease